BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS TORIC

    MDR report key: 21132305 · Received January 10, 2025

    Report

    Report Number
    3012236936-2025-000011
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 20, 2022
    Report Date
    February 6, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . SECTION D10: CONCOMITANT MEDICAL PRODUCTS: VERITAS VISION SYSTEM, SN UNKNOWN, VERITAS SWIVEL HANDPIECE, SN UNKNOWN, VRT-AI PACKS, LOT: UNKNOWN, J&J DISPOSABLE TIP (REPRESENTATIVE MODEL OPOCR4521L), J&J REUSABLE SLEEVE (REPRESENTATIVE MODELS OPOHF21L & OPOS21LD), CATALYS FS LASER (WITH LIQUID OPTICS INTERFACE GEN 2), J&J MOBILE PATIENT BED, BALANCED SALT SOLUTION (BSS) NO2, HEALON PRO AND SIMPLICITY SYSTEM (DELTA), GLAUCOMA IMPLANT (BG101-350), CATALOG #23030817, SN (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION (THE LENS REMAINS IMPLANTED) AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 YAG (YTTRIUM ALUMINUM GARNET) ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION/CLARIFICATION RECEIVED INDICATED THAT THIS IS A RETROSPECTIVE DATA COLLECTION STUDY AND THE SITES ARE COLLECTING DATA FROM 1 TO 2 YEARS AGO. THAT JOHNSON & JOHNSON BECAME AWARE OF THIS EVENT ON DECEMBER 16, 2024. CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THE THE INCORRECT DATE (DEC 17, 2024) WAS INADVERTENTLY ENTERED IN SECTION "G3" OF THE INITIAL MDR REPORT WHILE THE CORRECT DATE OF "DEC 16, 2024" SHOULD HAVE BEEN ENTERED. THE FOLLOWING FIELD HAS BEEN CORRECTED/UPDATED ACCORDINGLY: SECTION G3: DATE RECEIVED BY MANUFACTURER: 12/16/2024 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IN A CLINICAL STUDY CASE, A PATIENT UNDERWENT CATARACT/CLEAR LENS EXCHANGE AND GLAUCOMA SURGERY ON THE RIGHT EYE (OD). SUBSEQUENT POSTOPERATIVE (OP) VISITS REVEALED OCULAR FINDINGS. NO SURGICAL COMPLICATIONS, NO OTHER SURGICAL INTERVENTIONS REPORTED DURING THE INITIAL SURGERY. ON (B)(6) 2022, 1-WEEK POST-OP CATARACT SURGERY, ANTERIOR CHAMBER CELLS IN OD WERE NOTED. ON (B)(6) 2023, 6-MONTHS POST-OP CATARACT SURGERY, POSTERIOR CAPSULE OPACIFICATION (PCO) IN OD WAS NOTICED. SUTURE REMOVAL WAS INDICATED AS WELL. ON (B)(6), 2024, 12-MONTHS POST-OP CATARACT SURGERY, POSTERIOR CAPSULE OPACIFICATION (PCO) IN OD WAS REPORTED WHICH REQUIRED A YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY PROCEDURE ON (B)(6) 2024. THE STUDY ALSO REPORTED THAT A SECONDARY SURGICAL INTERVENTION AFTER GLAUCOMA SURGERY REQUIRED, WITH THE MODERATE SEVERITY WHICH THE GLAUCOMA TUBE NEEDED TRIMMING, ITS TIP SOMETIMES TOUCHED THE CORNEA. THE PRE-OP COMMENTS MENTIONED "TUBE WELL POSITIONED, NOT TOUCHING CORNEA CENTRALLY AT REST BUT ENDOTHELIAL OPACITY INDICATES TIP IS SOMETIMES TOUCHING CORNEA. PROBABLY WITH EYE RUBBING OR OTHER MOVEMENT. NEEDS TRIM." IT WAS NOTED THAT THE DEVICE IS BELIEVED TO HAVE ATTRIBUTED TO THE REPORTED EVENT. POST-OP COMMENTS STATED THAT TUBE IS LOOKING GOOD AND EXPLANT NOT PLANNED. THERE WAS NO DELAY IN PROCEDURE, NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THE POST-OP MEDICATION PRESCRIBED TO THE PATIENT WERE MOXIFLOXACIN HCL 0.5% AND PREDNISOLONE ACETATE 1%. THE ON JUNE 08, 2023, THE ISSUE WAS INDICATED AS RESOLVED WITHOUT SEQUELAE. NO FURTHER INFORMATION WAS REPORTED. THIS EMDR REPORT IS FOR THE TECNIS TORIC II INTRAOCULAR LENS (ZCU). A SEPARATE REPORT WILL BE SUBMITTED FOR THE GLAUCOMA IMPLANT (BG101-350).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505895 TECNIS TORIC INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNK-ZCU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention